Comparison Between Hemitrapeziectomy and Total Trapeziectomy With Ligament Reconstruction and Tendon Interposition in Trapeziometacarpal Osteoarthritis II-III Eaton-Littler
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Changes in the pollicis-lateral pinch strength
研究概览
简要总结
- Introduction:
Investigators think that surgery with preservation of healthy joints (hemitrapeziectomy) in trapeziometacarpal osteoarthritis without affecting sapho-trapezo-trapezoid joints, is better for scaphoid stability by preventing its collapse and thus preserving the stability of the carpus. 2. Objectives and Hypothesis:
Ligamentoplasty with partial trapeziectomy in grades II-III Eaton presents better results in the pollicis-lateral pinch (key pinch) strength than ligamentoplasty with total trapeziectomy.
Main Objective:
To demonstrate using the dynamometer that the postoperative key pinch strength higher using ligamentoplasty with partial trapeziectomy in grades II-III Eaton.
Secondary objectives:
To measure the collapse of the first column of thumb using calibrated radiographic analysis. Pain (E.V.A Scale). Range of motion (measured with goniometer). Quality of life (DISABILITIES OF THE ARM, SHOULDER AND HAND questionnaire). 3. Methodology:
It is a single-center randomized trial, parallel-group, in which two types of surgical techniques (TT - TP) will be compared. Patients will be randomized in this two techniques will be followed for one year, in routine clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Osteoarthritis in the trapeziometacarpal joint determined by the classification of Eaton-Littler (stages II-III) with trapeziometacarpal joint pain, loss of function, that were included in surgical waiting list and have accepted under informed consent, including the study.
排除标准
- •Patients with osteoarthritis Eaton-Littler (stage IV).
- •Patients with huge affection of trapezium subchondral cysts and poor quality of trabecular bone.
- •Cognitive impairment.
- •Old fracture with impairment of the same extremity.
- •Rheumatic active illness.
- •Patients who withdraw their informed consent, or in case of impossibility of opinion by clinical status, whose legal guardians or close relatives to withdraw their informed consent to participate in the study.
- •Patients who for any reason not related to the indication needed discontinue study participation or impossible to carry out assessments under more than two follow-up visits.
- •Patients in whom it is considered that participation in the clinical study can be a prejudice, the physician responsible for patient care opinion.
结局指标
主要结局
Changes in the pollicis-lateral pinch strength
时间窗: Before, three Months and One year after surgery.
In kilograms and measured with dynamometer.
次要结局
- Changes in range of motion(Before, three Months and One year after surgery.)
- Changes in Collapse of the first column of thumb using calibrated radiographic analysis(Before, three Months and One year after surgery.)
- Changes in pain score assessed with E.V.A Scale(Before, three Months and One year after surgery.)
- Changes in Quality of life assessed with the Disabilities of the arm, shoulder and hand questionnaire (DASH questionnaire)(Before, three Months and One year after surgery.)
研究者
Ferran Fillat Gomà
MD, MSc
Corporacion Parc Tauli